Bayer, The FDA & Confidential Yaz Documents

Bayer, The FDA & Confidential Yaz Documents

October 31st, 2011 // 11:52 am @

As a widely anticipated FDA advisory committee meeting nears, one of the many plaintiffs in the sprawling litigation involving the Yaz and Yasmin contraceptive pills has asked a federal court for permission to provide confidential documents to the agency in the belief that these may help the panel conduct its forthcoming review of risks and benefits.

For those who may not recall, the FDA is holding a December 8 meeting of both the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to examine the risk of blood clots caused by birth control pills containing drospirenone. The Bayer pills are among the most widely used brands (back story).

Yesterday, the FDA released a report indicating that women taking pills containing drospirenone were 74 percent more likely to experience clots than those on low-estrogen pills (read here). Separately, a study published this week in BMJ found a six-fold increased risk of venous thromboembolism, which are clots that can start in the leg but then travel to the lungs; this was twice the risk for women taking older contraceptives containing levonorgestrel (see this).

Meanwhile, in a brief filed in federal court in Illinois yesterday, lawyers for Kathryn Dietrick say she should be allowed to provide the FDA panel with nearly 50 documents – including clinical trials and case studies – that they claim the agency has not had a chance to previously review. They also want to provide documents indicating conflicts of interest among some of the FDA panel members.

Dietrick “possesses unique and detailed knowledge regarding risks (of venus thrombemboli), including internal and candid memoranda of clinical trial data and adverse event data not shared with the FDA,” her lawyers write. “Without plaintiff’s assistance, FDA may otherwise overlook significant safety information and public health risks.” And they argue that her First Amendment rights make a compelling case to ‘de-designate’ the documents (read more here).

What exactly is lurking in the documents is unclear, since they are currently under seal. But the brief underscores an issue that frequently shadows product-liability litigation – the numerous documents that are kept under wraps as part of the bargaining between drugmakers and plaintiffs to allow litigation to proceed. And judges generally approve these deals once the parties have agreed.

Drugmakers say such deals are needed to shield trade secrets. But these agreements have become so contentious that. earlier this year, the US Senate Judiciary Committee approved the “Sunshine in Litigation Act,” which would require judges to consider public health before granting a protective order or sealing court records and settlement agreements (back story).

Now, though, the lawyers for Dietrick – who maintains she was a healthy 17-year-old from Rochester, New York, who suffered a pulmonary embolism two years ago after taking Yaz for several months – are attempting to peel back the curtain on such arrangements. Whether they succeed remains to be seen, of course, but the outcome could alter the trajectory of many such lawsuits.

Interestingly, the lawyers cite an infamous instance in which confidential documents were leaked to the public in the name of public health. They referred to the litigation over the Zyprexa antipsychotic in which information about side effects was kept under seal, but surreptitiously disclosed by an expert witness and attorney who provided the material to a journalist, who then published some of the info.

The disclosure became a high-profile controversy and Eli Lilly, which sells Zyprexa, later agreed to plead guilty and pay $1.415 billion, which included a $515 million fine for a misdemeanor criminal charge, for off-label promotion. The judge overseeing that litigation sanctioned the attorney, who was not involved in the case, and the expert witness settled with the drugmaker (see this).

However, the same judge later acknowledged that “public access…is advisable, because this litigation involves issues of great public interest, the health of hundreds of thousands of people and fundamental questions about our system of approval and monitoring pharmaceutical products…Public disclosure, congruent with our long tradition of open courts, is desirable,” according to the brief.

Source: Pharmalot


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